Last updated: July 23, 2021
Sponsor: Shanghai Longyao Biotechnology Inc., Ltd.
Overall Status: Active - Recruiting
Phase
1
Condition
Adenocarcinoma
Treatment
N/AClinical Study ID
NCT04977193
LY011C1002
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be enrolled in this study:
- They were 18 to 70 years old, male or female; Histologically confirmed recurrent ormetastatic advanced gastric adenocarcinoma (including gastric adenocarcinoma at thegastroesophageal junction);
- Claudin 18.2 IHC staining was positive in tumor tissues;
- Patients with advanced gastric adenocarcinoma who are not cured by second-linechemotherapy and unwilling to accept second-line chemotherapy after failure offirst-line chemotherapy;
- Life expectancy > 12 weeks;
- According to RECIST 1.1, there was at least one measurable tumor target (≥ 10 mm);
- ECoG scores at screening, 24 hours before puncture and baseline (before treatment)were 0-1;
- Adequate organ function;
- For women of childbearing age with negative pregnancy test or male subjects, effectiveand reliable contraceptive methods must be adopted until 30 days after the end oftreatment;
- Have enough understanding ability to voluntarily sign informed consent to participatein clinical research.
Exclusion
Exclusion Criteria: Subjects who met any of the following criteria were not included in this study:
- The patients received the following anti-tumor treatment before transplantation:
- Cytotoxic treatment within 14 days
- Small molecule targeted therapy for 14 days or at least 5 half lives, whicheveris longer
- Experimental drug treatment within 28 days (if the above treatment is alsoexperimental drug treatment, the 28 day flushing period should be followed)
- The patients were treated with monoclonal antibody within 28 days
- Immunomodulatory therapy within 7 days
- Radiotherapy within 14 days
- Pregnant or lactating women;
- Serological positive for HIV, Treponema pallidum or HCV;
- Any uncontrollable active infection, including but not limited to active tuberculosisand HBV infection (HBsAg positive, HBcAb positive and HBV DNA positive);
- The subjects were judged as clinically significant thyroid dysfunction by theinvestigators (serum thyroid hormone determination TT4, TT3, FT3, FT4, serum thyroidstimulating hormone TSH) and were not suitable to participate in this study;
- The side effects caused by previous treatment did not recover to CTCAE ≤ 1;
- Subjects who are currently using steroids throughout the body within 7 days before depregnancy; Recent or recent use of inhaled steroids was not excluded;
- Any previous treatment for claudin 18.2;
- Previous allergy to immunotherapy and related drugs, severe allergy or allergichistory;
- T cells (including car-t and tcr-t) that have been modified by chimeric antigenreceptor;
- The subjects had untreated or symptomatic brain metastases;
- The subjects had central or extensive lung metastases;
- The subjects had heart disease requiring treatment or lost control of hypertensionafter treatment (blood pressure > 160 mmHg / 100 mmHg);
- Subjects with a history of organ transplantation or waiting for organ transplantation;
- There is no other serious disease that may restrict the subjects to participate inthis trial;
- The researcher assessed that the subjects were unable or unwilling to comply with therequirements of the study protocol;
- Blood oxygen saturation ≤ 95% before treatment (receiving finger oxygen test);
- Before pretreatment, subjects developed new arrhythmias, including but not limited toarrhythmias that could not be controlled by drugs, hypotension requiring vasopressin,bacterial, fungal or viral infections requiring intravenous antibiotics; Thecreatinine clearance rate was less than 40 ml / min; Investigators concluded that thesubject was not suitable for further study. Subjects who use antibiotics to preventinfection can continue the trial if the researcher makes a judgment;
- There are signs of central nervous system diseases or abnormal results of nervoussystem tests, which are of clinical significance;
- The subjects were suffering from or had other malignant tumors that could not be curedwithin 3 years, except for cervical cancer in situ or basal cell carcinoma of skin;
- known hypersensitivity to excipients and related adjuvants (including but not limitedto dimethyl sulfoxide and dextran-40) of the study drug;
- other conditions considered unsuitable by the researchers.
Study Design
Total Participants: 18
Study Start date:
November 01, 2021
Estimated Completion Date:
November 01, 2024
Connect with a study center
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu 221000
ChinaActive - Recruiting
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